Quality by Design for Primary Container Components

2015 ◽  
pp. 365-401
Author(s):  
Fran DeGrazio ◽  
Lionel Vedrine
Keyword(s):  
Quality By Design

The creation of quality by design

1962 ◽  
Vol 41 (10) ◽  
pp. 609
Author(s):  
B.H. Dyson
Keyword(s):  
Quality By Design ◽  
The Creation

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

Employment of Quality by Design approach via Response Surface Methodology to Optimize and Develop Modified Release formulation of Hydrochlorothiazide

2020 ◽  
Vol 16 ◽  
Author(s):  
Vikas D Singhai ◽  
Rahul Maheshwari ◽  
Swapnil Sharma ◽  
Sarvesh Paliwal
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Quality By Design ◽  
Management Tool ◽  
Contour Plot ◽  
P Value ◽  
Average Weight ◽  
Content Uniformity ◽  
Modified Release ◽  
Release Formulation

Background: Heart attack predominantly occurs during the last phase of sleep and early morning hours, causing millions of death worldwide. Hydrochlorothiazide (HCTZ) is recommended drug for the prevention of heart disease but its long action (>4 h) dosage form is lacking in the commercial market and development of extended-release formulation may have industrial significance. Regulatory agencies emphasize Quality by Design based approach for product development to entrust quality in the product. Objective: Aim of the current research was to develop a quality product profile of HCTZ modified-release tablets (MRT; ~14 h) by applying Response Surface Methodology using computational QbD approach. Methods: Three independent factors were identified by qualitative and quantitative risk assessment. Statistical terms like p-value, lack of fit, sum of square, R-squared value, model F value and linear equations were determined. Graphical tools like normal plot of residual, residual vs predicted plot and box cox plot were used to verify model selection. Graphical relationship among the critical, independent variables was represented using the Contour plot and 3-D surface plot. Design space was identified by designing overlay plot using response surface design. Results: Excellent correlation was observed between actual and predicted values. Similarity Factor (F2) of reproducible trials was 78 and 79 and content uniformity was 100.9% and 100.4%. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Conclusions: QbD approach along with quality risk management tool provided an efficient and effective paradigm to build quality MRT of HCTZ.

Optimization and Quality by Design Approach for Piroxicam Fast Dissolving Tablet Formulations Using Box-Behnken Design

2020 ◽  
Vol 15 (2) ◽  
pp. 152-165
Author(s):  
Harekrishna Roy ◽  
Sisir Nandi ◽  
Ungarala Pavani ◽  
Uppuluri Lakshmi ◽  
Tamma Saicharan Reddy ◽  
...  
Keyword(s):  
Quality By Design ◽  
Methyl Cellulose ◽  
Statistical Technique ◽  
Quadratic Model ◽  
Contour Plot ◽  
Compression Technique ◽  
Disintegration Time ◽  
Box Behnken Design ◽  
The Impact ◽  
The Relationship

Background: The present study deals with the formulation and optimization of piroxicam fast dissolving tablets and analyzes the impact of an independent variable while selecting the optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD). Methods: Seventeen formulations were prepared by direct compression technique by altering the proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose (HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C. Results: Significant quadratic model and second order polynomial equations were established using BBD. To find out the relationship between variables and responses, 3D response surface and 2D contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables from the mean point. An optimized formula was prepared based on the predicted response and the resulting responses were observed to be close with the predicted value. Conclusion: The optimized formulation with the desired parameter and formulation with variables and responses can be obtained by BBD and could be used in the large experiment with the involvement of a large number of variables and responses.

Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique

2016 ◽  
Vol 10 (3) ◽  
pp. 192-206
Author(s):  
Hetal Patel ◽  
Kishan Patel ◽  
Sanjay Tiwari ◽  
Sonia Pandey ◽  
Shailesh Shah ◽  
...  
Keyword(s):  
Quality By Design ◽  
Extrusion Spheronization
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